Patents Assigned to Intarcia Therapeutics, Inc.
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Patent number: 9889085Abstract: The present invention is directed to treatments for a disease or condition, in a subject in need thereof, that provide alternatives to treatment by injection that give, relative to treatment by injection, improved treatment outcomes, 100% treatment compliance, reduced side effects, and rapid establishment and/or termination of substantial steady-state drug delivery. The method includes providing continuous delivery of a drug from an implanted osmotic delivery device, wherein substantial steady-state delivery of the drug at therapeutic concentrations is achieved within about 7 days after implantation of the osmotic delivery device in the subject and the substantial steady-state delivery of the drug from the osmotic delivery device is continuous over a period of at least about 3 months. In one embodiment, the present invention is directed to treatment of type 2 diabetes mellitus using insulinotrophic peptides. In embodiments, a subject has a baseline HbA1c % of greater than 6.5% or 10.0%.Type: GrantFiled: September 30, 2015Date of Patent: February 13, 2018Assignee: INTARCIA THERAPEUTICS, INC.Inventors: Thomas R. Alessi, Michelle Baron
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Patent number: 9724293Abstract: A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.Type: GrantFiled: August 29, 2012Date of Patent: August 8, 2017Assignee: INTARCIA THERAPEUTICS, INC.Inventors: Rom Ezer Eliaz, Yuanpeng Zhang, Catherine Manya Rohloff, Eric William Weeks, Gunjan Junnarkar
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Patent number: 9682127Abstract: A suspension formulation of an insulinotropic peptide (e.g., glucagon-like peptide-1 (GLP-1) or exenatide) is described. The suspension formulation comprises (i) a non-aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a particle formulation comprising the insulinotropic peptide, wherein the peptide is dispersed in the vehicle. The particle formulation further includes a stabilizing component comprising one or more stabilizers, for example, carbohydrates, antioxidants, amino acids, and buffers. Devices for delivering the suspension formulations and methods of use are also described.Type: GrantFiled: October 12, 2016Date of Patent: June 20, 2017Assignee: INTARCIA THERAPEUTICS, INC.Inventors: Thomas R. Alessi, Ryan D. Mercer, Catherine M. Rohloff, Bing Yang
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Patent number: 9572889Abstract: The present invention relates to osmotic delivery devices, formulations, and methods for delivery of two or more beneficial agents. In one aspect, the present invention provides osmotic delivery devices useful for substantially concurrent administration of two or more beneficial agents. In another aspect, the present invention provides beneficial agent formulations for use in the osmotic delivery devices. The formulations include formulations wherein beneficial agents are soluble in the vehicle, suspension formulations comprising particle formulations of one or more beneficial agent, and combinations thereof. Further, methods for treatment of a variety of diseases or conditions using two or more beneficial agents are disclosed, wherein the methods are preferably practiced using the osmotic delivery devices and/or formulations of the invention.Type: GrantFiled: December 23, 2014Date of Patent: February 21, 2017Assignee: Intarcia Therapeutics, Inc.Inventors: Thomas R. Alessi, Karling Alice Leung, Ryan D. Mercer, Cristina G. Negulescu, Catherine M. Rohloff, Bing Yang
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Patent number: 9539200Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.Type: GrantFiled: February 26, 2015Date of Patent: January 10, 2017Assignee: Intarcia Therapeutics Inc.Inventors: Scott C. Lautenbach, Pedro E. De La Serna, Pauline C. Zamora, Michael A. Desjardin
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Patent number: 9526763Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.Type: GrantFiled: June 24, 2015Date of Patent: December 27, 2016Assignee: Intarcia Therapeutics Inc.Inventors: Catherine M. Rohloff, Guohua Chen, Andrew S. Luk, Rupal A. Ayer, Paul R. Houston, Michael A. Desjardin, Pauline Zamora, Stan Lam
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Patent number: 9095553Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.Type: GrantFiled: October 9, 2012Date of Patent: August 4, 2015Assignee: Intarcia Therapeutics Inc.Inventors: Catherine M. Rohloff, Guohua Chen, Andrew S. Luk, Rupal A. Ayer, Paul R. Houston, Michael A. Desjardin, Pauline Zamora, Stan Lam
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Patent number: 8992961Abstract: This invention relates to stable non-aqueous single phase viscous vehicles and to formulations utilizing such vehicles. The formulations comprise at least one beneficial agent uniformly suspended in the vehicle. The formulation is capable of being stored at temperatures ranging from cold to body temperature for long periods of time. The formulations are capable of being uniformly delivered from drug delivery systems at an exit shear rate of between about 1 to 1×10?7 reciprocal second.Type: GrantFiled: August 26, 2011Date of Patent: March 31, 2015Assignee: Intarcia Therapeutics, Inc.Inventors: Stephen A. Berry, Pamela J. Fereira, Houdin Dehnad, Anna Muchnik
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Patent number: 8992962Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.Type: GrantFiled: May 20, 2013Date of Patent: March 31, 2015Assignee: Intarcia Therapeutics Inc.Inventors: Scott D. Lautenbach, Pedro E. de la Serna, Pauline C. Zamora, Michael A. DesJardin
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Patent number: 8940316Abstract: A suspension formulation of an insulinotropic peptide (e.g., glucagon-like peptide-1 (GLP-1) or exenatide) is described. The suspension formulation comprises (i) a non-aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a particle formulation comprising the insulinotropic peptide, wherein the peptide is dispersed in the vehicle. The particle formulation further includes a stabilizing component comprising one or more stabilizers, for example, carbohydrates, antioxidants, amino acids, and buffers. Devices for delivering the suspension formulations and methods of use are also described.Type: GrantFiled: November 15, 2010Date of Patent: January 27, 2015Assignee: Intarcia Therapeutics, Inc.Inventors: Thomas R. Alessi, Ryan D. Mercer, Catherine M. Rohloff, Bing Yang
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Patent number: 8926595Abstract: The present invention relates to osmotic delivery devices, formulations, and methods for delivery of two or more beneficial agents. In one aspect, the present invention provides osmotic delivery devices useful for substantially concurrent administration of two or more beneficial agents. In another aspect, the present invention provides beneficial agent formulations for use in the osmotic delivery devices. The formulations include formulations wherein beneficial agents are soluble in the vehicle, suspension formulations comprising particle formulations of one or more beneficial agent, and combinations thereof. Further, methods for treatment of a variety of diseases or conditions using two or more beneficial agents are disclosed, wherein the methods are preferably practiced using the osmotic delivery devices and/or formulations of the invention.Type: GrantFiled: November 29, 2012Date of Patent: January 6, 2015Assignee: Intarcia Therapeutics, Inc.Inventors: Thomas R. Alessi, Karling Alice Leung, Ryan D. Mercer, Cristina G. Negulescu, Catherine M. Rohloff, Bing Yang
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Patent number: 8801700Abstract: An osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly further comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir.Type: GrantFiled: January 19, 2011Date of Patent: August 12, 2014Assignee: Intarcia Therapeutics, Inc.Inventors: Thomas R. Alessi, Michael A. DesJardin, Stan Lam, Scott D. Lautenbach, Pauline C. Zamora
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Publication number: 20130247376Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.Type: ApplicationFiled: May 20, 2013Publication date: September 26, 2013Applicant: INTARCIA THERAPEUTICS, INC.Inventors: Scott D. Lautenbach, Pedro E. de la Serna, Pauline C. Zamora, Michael A. DesJardin
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Patent number: 8535701Abstract: The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.Type: GrantFiled: October 4, 2012Date of Patent: September 17, 2013Assignee: Intarcia Therapeutics, Inc.Inventors: John R. Peery, Keith E. Dionne, Felix A. Landrau, Bonnie J. Eckenhoff, Scott D. Lautenbach, Judy A. Magruder, Jeremy C. Wright
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Patent number: 8470353Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.Type: GrantFiled: January 12, 2013Date of Patent: June 25, 2013Assignee: Intarcia Therapeutics, Inc.Inventors: Scott D. Lautenbach, Pedro E. de la Serna, Pauline C. Zamora, Michael A. DesJardin
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Patent number: 8460694Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.Type: GrantFiled: October 8, 2012Date of Patent: June 11, 2013Assignee: Intarcia Therapeutics, Inc.Inventors: Catherine M. Rohloff, Guohua Chen, Andrew S. Luk, Rupal A. Ayer, Paul R. Houston, Michael A. Desjardin, Pauline Zamora, Stan Lam
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Publication number: 20130138089Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.Type: ApplicationFiled: January 12, 2013Publication date: May 30, 2013Applicant: INTARCIA THERAPEUTICS, INC.Inventors: Scott D. Lautenbach, Pedro E. de la Serna, Pauline C. Zamora, Michael A. DesJardin
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Patent number: 8440226Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.Type: GrantFiled: June 18, 2012Date of Patent: May 14, 2013Assignee: Intarcia Therapeutics, Inc.Inventors: Catherine M. Rohloff, Guohua Chen, Andrew S. Luk, Rupal A. Ayer, Paul R. Houston, Michael A. Desjardin, Pauline Zamora, Stan Lam
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Publication number: 20130090287Abstract: The present invention relates to osmotic delivery devices, formulations, and methods for delivery of two or more beneficial agents. In one aspect, the present invention provides osmotic delivery devices useful for substantially concurrent administration of two or more beneficial agents. In another aspect, the present invention provides beneficial agent formulations for use in the osmotic delivery devices. The formulations include formulations wherein beneficial agents are soluble in the vehicle, suspension formulations comprising particle formulations of one or more beneficial agent, and combinations thereof. Further, methods for treatment of a variety of diseases or conditions using two or more beneficial agents are disclosed, wherein the methods are preferably practiced using the osmotic delivery devices and/or formulations of the invention.Type: ApplicationFiled: November 29, 2012Publication date: April 11, 2013Applicant: INTARCIA THERAPEUTICS, INC.Inventors: Thomas R. Alessi, Karling Alice Leung, Ryan D. Mercer, Cristina G. Negulescu, Catherine M. Rohloff, Bing Yang
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Patent number: 8398967Abstract: A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.Type: GrantFiled: April 21, 2011Date of Patent: March 19, 2013Assignee: Intarcia Therapeutics, Inc.Inventors: Rom Ezer Eliaz, Yuanpeng Zhang, Catherine Manya Rohloff, Eric William Weeks, Gunjan Junnarkar